Tibial Nail ADVANCED Semi-Extended Parapatellar Approach Instruments and implants approved by the AO Foundation. Image intensifier control This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended. Processing, Reprocessing, Care and Maintenance For general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance For general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance Table of Contents Introduction AO Principles 2 Indications 3 Surgical Technique Opening the Tibia 4 Nail Insertion 13 Distal Locking 28 Proximal Locking 35 End Cap Insertion 48 Implant Removal 49 Product Information Implants 54 Alternative Instruments 56 Instruments 58 Optional Instruments 64 Semi-extended Parapatellar Approach Surgical Technique DePuy Synthes 1 AO Principles AO PRINCIPLES In 1958, the AO formulated four basic principles, which haveIn 1958, become the AO the formulated guidelines forfour internal basic principles, fixation1,2 .which have become the guidelines for internal fixation1, 2. 4_Priciples_03.pdf 1 05.07.12 12:08 FunctionalAnatomic reduction reduction Stable fixation FractureFracture reductionreduction andand fifixationxation to Fracture fixation providing absoluteabso- to restore restore anatomical anatomical relationships. relationships. orlute relative or relative stability, stability, as required as by therequired patient, by thethe patient,injury, and the the injury, per - 1 2 sonalityand the ofpersonality the fracture. of the fracture. Early,Early, active mobilization Preservation ofof bloodblood supplysupply EarlyEarly andand safesafe mobilizationmobilization andand 4 3 Preservation of the blood supply rehabilitation rehabilitation ofof thethe injuredinjured partpart to soft tissues and bone by gentle andand thethe patientpatient asas aa whole.whole. reductiongentle reduction techniques techniques and careful and handling.careful handling. 1 Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 1991. 2 Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007. 1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer. 1991. 2. Rüedi TP, Buckley RE, Moran CG. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007. 24 DDeePuy Synthes ESuxprgeirct aLl aTtercahln Fieqmueo raSl eNmaiil- exStuenrgdiecda lP Taercahpnatieqlulear Approach Indications The Tibial Nail Advanced implants are intended for treat- ment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the im- plants are indicated for: • Open and closed proximal and distal tibia fractures • Open and closed tibial shaft fractures • Tibial malunions and nonunions Contraindications: No contraindications specific to these devices. Warnings • It is critical to ensure proper selection of the implant meets the needs of the patient anatomy and the presenting trauma. Physician should consider reaming to avoid under-sizing, to improve fit of nail, and to accelerate bone healing. • Use of these devices is not recommended when there is systemic infection, infection localized to the site of the proposed implantation or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials. • Physician should consider patient bone quality to ensure it provides adequate fixation to promote healing. • Conditions that place excessive stresses on bone and implant such as severe obesity or degenerative diseases, should be considered. The decision whether to use these devices in patients with such conditions must be made by the physician taking into account the risks versus the benefits to the patients. • Compromised vascularity in the site of proposed implantation may prevent adequate healing and thus preclude the use of this or any orthopaedic implant. • Physician should take into account an increase in medullary pressure occurring during medullary nailing or reaming. This releases varying amounts of bone marrow and fat into the venous blood system. Semi-extended Parapatellar Approach Surgical Technique DePuy Synthes 3 Opening the tibia 1 1A Position patient 1A Position the patient supine on the radiolucent table. Ensure that the knee of the injured leg is fl exed about 10° – 30° by using a knee roll or hydraulic leg holder. The knee roll can be placed under the lower part of the thigh if it obstructs the view of the tibial plateau in the AP view. 1B Position the image intensifi er so that visualization of the tibia, including the articular surface proximally and distally, is possible in AP and lateral views. 1A 4 DePuy Synthes Surgical Technique Semi-extended Parapatellar Approach 2 2B Reduce fracture 2A Perform closed reduction manually by axial traction under image intensifi er. 2B The use of a large distractor may be appropriate in certain circumstances. Notes: The reduction can be temporarily fi xed with reduction clamps. In epiphyseal fractures, the con- dyles or the pilon are fi xed fi rst in order to enable the nail insertion. 3 3B Make incision 3A The medial and lateral laxity of the patella is taken into consideration. The path of least resistance, as di- rected by patellar laxity and patient anatomy, determines whether a medial or lateral patellar approach is made. 3B Medial or lateral incision is made depending on which incision will allow for the easiest access to the ap- propriate starting point just medial to the lateral tibial spine at the anterior articular margin 3D 3C Incise to the patellar retinaculum without violating the retinaculum. Elevate the retinaculum from the under- lying synovium. Divide the retinaculum while leaving a 2 to 3 mm cuff of tissue on the patella for later repair. 3D The patella is then subluxed laterally or medially to allow direct access to the proximal tibial starting point. Semi-extended Parapatellar Approach Surgical Technique DePuy Synthes 5 Opening the tibia 4 4A Determine entry point Instruments 03.043.002 Awl 4A In the frontal view the entry point is in line with the axis of the intramedullary canal and with the lateral tu- bercle of the intercondylar eminence. 4B In the sagittal view the entry point is at the ventral edge of the tibial plateau. 4B Precaution: Deviation from the optimal entry portal may cause irreducible malalignment, iatrogenic bone and soft tissue damage, malunion, and non- 10º union. 6 DePuy Synthes Surgical Technique Semi-extended Parapatellar Approach 4C Use the awl to determine the appropriate entry point. 4C 4D Check the position under imaging in the AP and lat- eral views. 4D Semi-extended Parapatellar Approach Surgical Technique DePuy Synthes 7 Opening the tibia 4E Use the awl to make an indentation at the appropriate entry point. 4E The blunt side of the awl is used to prevent the patella from sliding back into the trochlear groove. 8 DePuy Synthes Surgical Technique Semi-extended Parapatellar Approach 5. Open medullary canal 5A Instruments 03.010.500 Silicone Handle With Quick Coupling 03.043.003 Protection Sleeve 03.043.004 Wire Guide 03.045.018 Guide Wire 03.043.016 Drill Bit 5A Attach the handle to the protection sleeve and insert the assembly through the incision towards the entry point, so that it rests in the trochlear groove, while the patella is subluxed. 5B The protection sleeve will protect the patello-femoral joint during the passage of instrumentation into the medullary canal. Precaution: Pay special attention not to penetrate the posterior cortex. 5C Insert a guide wire through the wire guide into the bone to a depth of approximately 8 cm – 10 cm. Check Remove the drill bit and guide wire. the position under imaging in the AP and lateral views. When using 12 and 13 mm nails, the opening must be over-reamed by at least 1 mm using a bedullary reamer 5D Adjustments to the guide wire location can be "di- system. aled-in" by rotating the wire guide to place a second Precaution: Do not start the drill inside the protec- guide wire while the fi rst guide wire remains in place. tion sleeve. Note: Dispose of the guide wire. Do not reuse. 5E After correct placement of the second guide wire, re- move the initial, central guide wire. 5F Remove the wire guide from the protection sleeve and place the drill bit over the guide wire, through the protection sleeve, and down to the bone. Use a protec- tion sleeve to prevent damage to the surrounding soft tissue, monitor that the tip of the protection sleeve re- mains in direct contact to the proximal tibia. 5G Drill to a depth of approximately 8 – 10 cm. Semi-extended Parapatellar Approach Surgical Technique DePuy Synthes 4 Opening the tibia 5.OPT.: Reaming Rod 5.OPT.A Instruments 03.233.011 Reaming Rod, 3 mm, L 1150 mm 03.010.495 IMN Reduction Tool 03.010.496 T-Handle With Quick Coupling 03.010.093 Rod Pusher 5.OPT.A The use of a reaming rod can facilitate reduc- tion, serve as a guide for intramedullary reamers, and aids in keeping bone fragments aligned during nail inser- tion. Precaution: The Tibial Nail Advanced is cannulated and can be inserted over reaming rods with a diam- eter of up to 3.8 mm at their widest point. Compati- ble reaming rods will pass through the hole in the center of the aiming arm. 5.OPT.B The IMN reduction tool may be used to aid in 5.OPT.B achieving alignment of the proximal and distal frag- ments, and for guiding the reaming rod into the distal fragment.